Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089885
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | No |
NITROGLYCERIN | NITROGLYCERIN | 0.1MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/30/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/89885_Nitroglycerin%20Transdermal_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/89884ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/089885_nitroglycerin_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/14/2001 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
06/14/2001 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
06/14/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/21/2000 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/30/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/89885_Nitroglycerin%20Transdermal_Prntlbl.pdf |
NITROGLYCERIN
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.4MG/HR
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 074559 | MYLAN TECHNOLOGIES |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 089885 | ZYDUS PHARMS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/HR
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.1MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 074559 | MYLAN TECHNOLOGIES |
NITROGLYCERIN | NITROGLYCERIN | 0.1MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 089885 | ZYDUS PHARMS |